| CTRI Number |
CTRI/2025/06/089006 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of hyperbaric solutions of bupivacaine, levobupivacaine and ropivacaine in spinal anaesthesia for elective surgery: a prospective randomised double-blind study |
|
Scientific Title of Study
|
Comparison of hyperbaric solutions of Bupivacaine,
Levobupivacaine and Ropivacaine in Spinal anaesthesia for
elective surgery: A prospective, Randomised, double-blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishani Chawla |
| Designation |
Junior Resident |
| Affiliation |
H.B.T.M.C and Dr R.N. Cooper hospital, Mumbai |
| Address |
Department of Anaesthesiology, H.B.T.M.C and Dr R.N Cooper hospital, Ville Parle west, Mumbai
Mumbai
MAHARASHTRA
400056
India |
| Phone |
7795362668 |
| Fax |
|
| Email |
aishanichawla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naina Dalvi |
| Designation |
Additional Professor |
| Affiliation |
H.B.T.M.C and Dr R.N. Cooper hospital, Mumbai |
| Address |
Department of Anaesthesiology, H.B.T.M.C and Dr R.N Cooper hospital, Ville Parle west, Mumbai
Mumbai
MAHARASHTRA
400056
India |
| Phone |
7795362668 |
| Fax |
|
| Email |
drnaina@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishani Chawla |
| Designation |
Junior Resident |
| Affiliation |
H.B.T.M.C and Dr R.N. Cooper hospital, Mumbai |
| Address |
Department of Anaesthesiology, H.B.T.M.C and Dr R.N Cooper hospital, Ville Parle west, Mumbai
Mumbai
MAHARASHTRA
400056
India |
| Phone |
7795362668 |
| Fax |
|
| Email |
aishanichawla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aishani Chawla |
| Department of Anesthesiology , Hinduhrudaysamrat Balasaheb Thackeray Medical College and Dr R.N. Cooper hospital, Ville Parle west, Mumbai -400056 |
|
|
Primary Sponsor
|
| Name |
HBTMC and Dr RN Cooper hospital |
| Address |
Department of Anaesthesiology, H.B.T.M.C and Dr R.N Cooper hospital, Ville Parle west, Mumbai |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aishani Chawla |
Dr R.N.Cooper hospital |
Department of Anesthesiology, H.B.T.MC and Dr R.N.Cooper hospital, Ville Parle west, Mumbai 400056
Mumbai
MAHARASHTRA |
7795362668
aishanichawla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Comitee, H.B.T.M.C |
Approved |
| Instituitional Ethics Comitee, H.B.T.M.C |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K612||Anorectal abscess, (2) ICD-10 Condition: N819||Female genital prolapse, unspecified, (3) ICD-10 Condition: N979||Female infertility, unspecified, (4) ICD-10 Condition: N433||Hydrocele, unspecified, (5) ICD-10 Condition: O||Medical and Surgical, (6) ICD-10 Condition: O||Medical and Surgical, (7) ICD-10 Condition: O021||Missed abortion, (8) ICD-10 Condition: K36||Other appendicitis, (9) ICD-10 Condition: N849||Polyp of female genital tract, unspecified, (10) ICD-10 Condition: N434||Spermatocele of epididymis, (11) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (12) ICD-10 Condition: K469||Unspecified abdominal hernia without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyperbaric Bupivacaine |
administeration of spinal anesthesia drug in consenting patients; 0.5% Hyperbaric Bupivacaine intrathecally; for duration of surgery |
| Comparator Agent |
Hyperbaric Levobupivacaine |
administeration of spinal anesthesia drug in consenting patients; 0.5% Hyperbaric Levobupivacaine intrathecally; for duration of surgery |
| Comparator Agent |
Hyperbaric Ropivacaine |
administeration of spinal anesthesia drug in consenting patients; 0.5% Hyperbaric Bupivacaine intrathecally; for duration of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II |
|
| ExclusionCriteria |
| Details |
ASA III and IV
Blood Dyscrasias
Clotting disorders
Pregnant and Lactating
History of hypersensitivity disorders
Pain modifying drugs
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset and duration of sensory blockade with the three drugs
|
assessement done every minute till 5 minutes, every 5 minutes thereafter till end of procedure; post procedure assesment done evry 30 min till level recedes completely
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Onset & duration of motor blockade
2. Effect on heart rate
3. Effect on MAP
4. Effect on PONV
|
1. assessement done every minute till 5 minutes, every 5 minutes thereafter till end of procedure; post procedure assesment done evry 30 min till level recedes completely
2. assessement done every minute till 5 minutes, every 5 minutes thereafter till end of procedure.
3. assessement done every minute till 5 minutes, every 5 minutes thereafter till end of procedure.
4. Intra operative & post operative till 24 hours |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We are comparing bupivacaine with ropivacaine
and levobupivacaine with the aim of
studying clinical efficacy
of hyperbaric bupivacaine, levobupivacaine and ropivacaine with respect to sensory and motor block characteristics, haemodynamic
parameters and adverse effects.
Seventy five patients satisfying the
inclusion and exclusion criteria undergoing elective lower limb and lower
abdominal surgeries will be enrolled in our study after obtaining written informed
consent. Patients will be randomly allocated into 3 groups of 25 each, receiving 3 ml of 0.5% hyperbaric bupivacaine,
levobupivacaine and ropivacaine.
All data
will be compiled in a case record form. Data will be analysed using SPSS v21. Chi
square test will be used as test of significance for categorical data and
ANOVA test will be used as test of significance for continuous data (comparison of
three groups means). Post hoc comparative analysis will be done to determine
statistical significance among the three groups. P value less than 0.05 would considered as statistically significant.
The demographic data such as age, sex, height, weight and ASA grades, operative procedures and duration
of surgery would be collected. Parameters noted in case record form will be :
- Mean Time of onset of sensory block (T8)
- Mean Time to reach peak sensory block
- Maximal sensory level was
assessed;
- Time for 2 segment regressions of
sensory level
- The mean
Duration of sensory blockade (Tanes)
- The mean Onset time of motor blockade
- The mean Duration
of Motor Blockade
- Haemodynamic parameters like pulse rate, blood pressure, respiratory rate and saturation
- Mean
arterial pressure
- The mean Time taken to Walk without
support
- The mean Time taken to Void
- Perioperative adverse events
|